AccessGUDID - DEVICE: Prosthetic Silicone Materials (05060483016252)

GUDID

Device Identifier (DI) Information

Brand Name: Prosthetic Silicone Materials
Version or Model: Softening Agent (25g)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M513(25)
Company Name: TECHNOVENT LIMITED

Primary DI Number: 05060483016252
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 225835156 *Terms of Use

Device Description: Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials. The softening agent is an additive to reduce the hardness of cured M511 silicone rubber. The Gel Part B is an alternative cross-linker for M511 which creates a gel material, rather than a rubber.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16730	Dental appliance fabrication material, resin	A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBI	Material, External Aesthetic Restoration, Used With Adhesive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.
Special Storage Condition, Specify: The Softening Agent and Gel Part B are supplied in plastic dropper bottles and it is recommended that they are stored in their original containers. Store out of direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69aadcd8-dc1b-44ab-85ab-8a61b0b123f9
Public Version Date: July 30, 2024
Public Version Number: 1
DI Record Publish Date: July 22, 2024